Diotame (Oral)

Bismuth subsalicylate is used to treat diarrhea in adults and teenagers. It is also used to help with upset stomach symptoms, like heartburn, indigestion, and nausea in adults and teenagers.

This medicine can be bought without a prescription.

Check the labels of all over-the-counter (OTC), nonprescription, and prescription medicines you are currently taking. Be especially careful if any contain aspirin or other salicylates. Using other salicylate-containing products while taking this medicine may lead to overdose. If you have any questions about this, ask your health care professional.

For diabetic patients:

• False urine sugar test results may happen if you are regularly taking large amounts of bismuth subsalicylate or other salicylates.
• Smaller doses or occasional use of bismuth subsalicylate usually will not affect urine sugar tests. However, check with your health care professional (especially if your diabetes is not well-controlled) if: you are unsure how much salicylate you are taking each day, you notice any change in your urine sugar test results, you have any other questions about this possible issue.

If you think that you or anyone else may have taken an overdose, get emergency help immediately. Taking an overdose of this medicine may cause unconsciousness or death. Signs of overdose include convulsions (seizures), hearing loss, confusion, ringing or buzzing in the ears, severe drowsiness or tiredness, severe excitement or nervousness, and fast or deep breathing.

If you are taking this medicine for diarrhea, check with your doctor:

• if your symptoms do not improve within 2 days or if they worsen.
• if you also have a high fever.

In deciding to use a medicine, you must consider the risks of taking the medicine against the benefits it will provide. This is a choice you will make with your doctor. For this medicine, the following should be taken into account:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients closely.

Pediatric

This medicine should not be given to children younger than 12 years old. Diarrhea can lead to severe fluid loss. In older children with diarrhea, medicine for diarrhea may be used, but it is also very important to give enough liquids to replace the fluid that has been lost. If you have questions about this, consult your healthcare professional.

Additionally, children are generally more sensitive to salicylates, especially if they have a fever or have lost a lot of fluids from vomiting, diarrhea, or sweating.

The bismuth in this medicine may cause severe constipation in children.

Furthermore, do not use this medicine to treat nausea or vomiting in children or teenagers who have or are recovering from the flu or chickenpox. If nausea or vomiting occurs, consult the child's doctor immediately, as this could be an early sign of Reye's syndrome.

Geriatric

Diarrhea can lead to severe fluid loss. For this reason, elderly individuals with diarrhea should not take this medicine without first consulting their doctor. It is also very important to drink enough liquids to replace the fluid lost by the body. If you have questions about this, check with your healthcare professional.

Additionally, older adults may be more sensitive to salicylates, which can increase the risk of side effects during treatment. Also, the bismuth in this medicine may cause severe constipation in older adults.

Breast Feeding

Studies on breastfeeding women have shown harmful effects on infants. An alternative medication should be prescribed, or you should stop breastfeeding while taking this medicine.

Interactions with Medicines

Some medicines should not be taken together at all, while others may be used together even if an interaction could happen. In these cases, your doctor may need to adjust the dose, or other precautions may be necessary. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while using this medicine. The interactions listed are based on their potential significance but are not necessarily complete.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Aceclofenac
• Acemetacin
• Amtolmetin Guacil
• Balsalazide
• Bromfenac
• Bufexamac
• Celecoxib
• Choline Magnesium Trisalicylate
• Choline Salicylate
• Clonixin
• Dexibuprofen
• Dexketoprofen
• Diflunisal
• Digoxin
• Dipyrone
• Droxicam
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Furosemide
• Ibuprofen
• Ketoprofen
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Magnesium Salicylate
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Mesalamine
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Olsalazine
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Phenyl Salicylate
• Piketoprofen
• Piroxicam
• Proglumetacin
• Propyphenazone
• Proquazone
• Rofecoxib
• Salicylamide
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sulfasalazine
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Trolamine Salicylate
• Valdecoxib

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both medications may be the best option for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Doxycycline
• Omadacycline
• Probenecid
• Sulfinpyrazone
• Tamarind

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around mealtime or with certain foods due to possible interactions. Using alcohol or tobacco with some medicines can also lead to interactions. Discuss with your healthcare professional how to take your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical conditions may affect how you use this medicine. Make sure to inform your doctor if you have any other medical issues, particularly:

• Dysentery—This condition may worsen; a different treatment may be necessary.

• Gout—The salicylate in this medicine may worsen gout and reduce the effectiveness of gout medications.

• Hemophilia or other bleeding issues—The salicylate in this medicine may increase the risk of bleeding.

• Kidney disease—There is a higher chance of side effects because the body may not be able to eliminate the bismuth subsalicylate effectively.

• Stomach ulcer—Using this medicine may aggravate the ulcer.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do occur, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

In some patients, bismuth subsalicylate may cause a dark tongue and/or grayish black stools. This is only temporary and will go away when you stop taking this medicine.

• Anxiety
• any loss of hearing
• confusion
• constipation (severe)
• diarrhea (severe or continuing)
• difficulty in speaking or slurred speech
• dizziness or lightheadedness
• drowsiness (severe)
• fast or deep breathing
• headache (severe or continuing)
• increased sweating
• increased thirst
• mental depression
• muscle spasms (especially of face, neck, and back)
• muscle weakness
• nausea or vomiting (severe or continuing)
• ringing or buzzing in ears (continuing)
• stomach pain (severe or continuing)
• trembling
• uncontrollable flapping movements of the hands (especially in elderly patients) or other uncontrolled body movements
• vision problems

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Bismatrol
• Diotame
• Kaopectate
• Kapectolin
• Kola-Pectin
• Pepto Bismol

In Canada

• Bismuth Extra Strength
• Bismuth Original Formula
• Compliments Bismuth - Regular Strength
• Exact Bismuth - Extra Strength
• Exact Bismuth - Regular Strength
• GoodSense Bismuth - Regular Strength
• Life Brand Bismuth - Extra Strength
• Life Brand Bismuth - Regular Strength
• Option+ Bismuth - Regular Strength
• Pepto-Bismol
• Pharmasave Bismuth - Regular Strength
• Selection Bismuth - Regular Strength

Available Dosage Forms:

• Suspension
• Tablet, Chewable
• Capsule, Liquid Filled
• Tablet

Therapeutic Class: Antacid, Bismuth Containing

Chemical Class: Salicylate, Non-Aspirin

Make certain your health care professional knows if you are on any special diet, such as a low-sodium or low-sugar diet.

For safe and effective use of this medicine:

• Follow your doctor's instructions if this medicine was prescribed.
• Follow the manufacturer's package directions if you are treating yourself.

For patients using this medicine to treat diarrhea:

• It is very important that the fluid lost by the body be replaced and that a proper diet be followed. For the first 24 hours you should drink plenty of clear liquids, such as ginger ale, decaffeinated cola, decaffeinated tea, broth, and gelatin. During the next 24 hours you may eat bland foods, such as cooked cereals, bread, crackers, and applesauce. Fruits, vegetables, fried or spicy foods, bran, candy, and caffeine and alcoholic beverages may make the diarrhea worse.
• If too much fluid has been lost by the body due to the diarrhea a serious condition may develop. Check with your doctor as soon as possible if any of the following signs of too much fluid loss occur: Decreased urination Dizziness and lightheadedness Dryness of mouth Increased thirst Wrinkled skin

If you are taking the oral suspension: Use the dose cup that is included to measure out the right amount of medicine. If you are unsure, contact your doctor or pharmacist.

If you are taking the oral tablets: Swallow the tablet whole with a glass of water. Do not crush or chew the tablet.

If you are taking the chewable tablets: Chew up the tablet or allow it to completely disintegrate in your mouth before swallowing it.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (suspension): For diarrhea or upset stomach: Adults and teenagers—The usual dose is 2 tablespoonfuls every half-hour to one hour if needed. You should not take more than 16 tablespoonfuls of the regular-strength suspension or 8 tablespoonfuls of the concentrate in twenty-four hours. Children—Should not be used in children younger than 12 years of age.
• For oral dosage forms (tablets or chewable tablets): For diarrhea or upset stomach: Adults and teenagers—The usual dose is 2 tablets every half-hour to one hour. You should not take more than 16 tablets in twenty-four hours. Children—Should not be used in children younger than 12 years of age.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

• What causes black hairy tongue?